BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 3163224 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-07006
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED INFORMATION: THE ACTUAL DEVICE LOT NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THERE ARE TWO POSSIBLE LOT NUMBERS, 3270173 AND 3270174, THAT CAN BE ASSOCIATED WITH THIS EVENT. IN ADDITION, A REVIEW OF THE LOT MANUFACTURING RECORDS FOR THE POSSIBLE LOT NUMBERS WAS CONDUCTED AND THE LOTS MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE LOT NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THERE ARE TWO POSSIBLE LOT NUMBERS, 3270173 AND 3270174, THAT CAN BE ASSOCIATED WITH THIS EVENT. LOT NUMBER 3270173 WAS MANUFACTURED ON 2/10/2009 AND HAS AN EXPIRATION DATE OF 8/31/2011. LOT NUMBER 3270174 WAS MANUFACTURED ON 2/18/2009 AND HAS AN EXPIRATION DATE OF 8/31/2011. BOTH LOT NUMBERS HAVE THE PRODUCT CODE PFRA02. ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, RECURRENCE, VAGINAL SCARRING AND DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2009 DUE TO EROSION. (B)(4) ¿UNDEFINED RECURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH AND MINIARC SLING WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264159 PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3205544

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MINIARC SLING